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COMET India Follow-up Trial

Primary Purpose

Depressive Symptoms, Anxiety, Happiness

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Common Elements Toolbox
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depressive Symptoms

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • College Student
  • Access to internet
  • Proficient in English

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Common Elements Toolbox

    Wait-list control

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in Patient Health Questionnaire-9 (PHQ-9)
    Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.
    Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
    Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
    Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
    Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.

    Secondary Outcome Measures

    Ratings on the Acceptability of Intervention Measure (AIM)
    Questionnaire measuring the acceptability of an intervention. Acceptability refers to the perception that a given treatment is agreeable or satisfactory. The total score ranges from 4 to 20. Higher scores indicate higher acceptability ratings.
    Ratings on the Intervention Appropriateness Measure (IAM)
    Questionnaire measuring the appropriateness of an intervention. Appropriateness refers to the perceived fit or relevance of an intervention. The total score ranges from 4 to 20. Higher scores indicate higher appropriateness.
    Mechanisms of Change
    Participants answered questions relating to each module's mechanism of change on a 7-point Likert Scale, from "strongly disagree" to "strongly agree". Specifically, we asked participants: How capable they feel about managing negative thoughts; If they will intentionally spend time doing activities they enjoy; If they will notice and appreciate good things; If they will
    Secondary Control
    We asked participants three items to assess secondary control (Weisz et al., 2010). The items are scored on a 4-point Likert scale, ranging from 0 ("Very false") to 3 ("Very true"). The three items are: When something bad happens, I can find a way to think about it that makes me feel better. After a really hard day, I can make myself feel better by remembering some good things that happened. When bad things happen to me that I can't control, there are lots of things I can do to feel better. Higher scores indicate greater secondary control.
    Positive and Negative Affect Schedule
    Questionnaire measuring positive affect and negative affect. Scores on the positive affect subscale range from 10-50, with higher scores representing higher levels of positive affect. Scores on the negative affect subscale range from 10-50, with lower scores representing lower levels of negative affect.
    Perceived Stress Scale-4
    Questionnaire measuring perceived stress. Scores range from 0-16, with higher scores indicating greater stress.

    Full Information

    First Posted
    November 16, 2021
    Last Updated
    July 10, 2023
    Sponsor
    University of Pennsylvania
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05138120
    Brief Title
    COMET India Follow-up Trial
    Official Title
    Evaluating an Online Single-session Intervention (COMET) for Indian College Students
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    lack of enrollment
    Study Start Date
    November 20, 2021 (Anticipated)
    Primary Completion Date
    November 20, 2022 (Actual)
    Study Completion Date
    November 20, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Pennsylvania

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    We are evaluating an online single-session intervention for mental health promotion among Indian college students.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depressive Symptoms, Anxiety, Happiness

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Common Elements Toolbox
    Arm Type
    Experimental
    Arm Title
    Wait-list control
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Common Elements Toolbox
    Intervention Description
    An unguided online single-session intervention with four modules: behavioral activation, cognitive restructuring, gratitude, and self-compassion.
    Primary Outcome Measure Information:
    Title
    Change in Patient Health Questionnaire-9 (PHQ-9)
    Description
    Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.
    Time Frame
    Up to 8 weeks post-intervention
    Title
    Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
    Description
    Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
    Time Frame
    Up to 8 weeks post-intervention
    Title
    Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
    Description
    Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.
    Time Frame
    Up to 8 weeks post-intervention
    Secondary Outcome Measure Information:
    Title
    Ratings on the Acceptability of Intervention Measure (AIM)
    Description
    Questionnaire measuring the acceptability of an intervention. Acceptability refers to the perception that a given treatment is agreeable or satisfactory. The total score ranges from 4 to 20. Higher scores indicate higher acceptability ratings.
    Time Frame
    Immediately after the intervention
    Title
    Ratings on the Intervention Appropriateness Measure (IAM)
    Description
    Questionnaire measuring the appropriateness of an intervention. Appropriateness refers to the perceived fit or relevance of an intervention. The total score ranges from 4 to 20. Higher scores indicate higher appropriateness.
    Time Frame
    Immediately after the intervention
    Title
    Mechanisms of Change
    Description
    Participants answered questions relating to each module's mechanism of change on a 7-point Likert Scale, from "strongly disagree" to "strongly agree". Specifically, we asked participants: How capable they feel about managing negative thoughts; If they will intentionally spend time doing activities they enjoy; If they will notice and appreciate good things; If they will
    Time Frame
    Up to 8 weeks post-intervention
    Title
    Secondary Control
    Description
    We asked participants three items to assess secondary control (Weisz et al., 2010). The items are scored on a 4-point Likert scale, ranging from 0 ("Very false") to 3 ("Very true"). The three items are: When something bad happens, I can find a way to think about it that makes me feel better. After a really hard day, I can make myself feel better by remembering some good things that happened. When bad things happen to me that I can't control, there are lots of things I can do to feel better. Higher scores indicate greater secondary control.
    Time Frame
    Up to 8 weeks post-intervention
    Title
    Positive and Negative Affect Schedule
    Description
    Questionnaire measuring positive affect and negative affect. Scores on the positive affect subscale range from 10-50, with higher scores representing higher levels of positive affect. Scores on the negative affect subscale range from 10-50, with lower scores representing lower levels of negative affect.
    Time Frame
    Up to 8 weeks post-intervention
    Title
    Perceived Stress Scale-4
    Description
    Questionnaire measuring perceived stress. Scores range from 0-16, with higher scores indicating greater stress.
    Time Frame
    Up to 8 weeks post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: College Student Access to internet Proficient in English Exclusion Criteria: -

    12. IPD Sharing Statement

    Learn more about this trial

    COMET India Follow-up Trial

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